WEEKLY IMPORTANT NEWS FROM MEDSCAPE AND OTHER SOURCES
Δευτέρα, 8 Μαΐου 2017
NIVOLUMAB APPROVED BY HEAD AND NECK CANCER BY EMA
On April 28, the European Commission approved nivolumab (Opdivo) as monotherapy for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in adults with disease progression on or after platinum-based therapy. Nivolumab is the first and only immuno-oncology treatment that has demonstrated significant improvement in overall survival for these patients in a phase III trial setting. The drug was approved for this indication by the U.S. Food and Drug Administration in November 2016.
“Adult patients with squamous cell cancer of the head and neck that progresses on or after platinum-based therapy are fighting a debilitating and hard-to-treat disease that is associated with a very poor prognosis,” said Kevin Harrington, MD, PhD, Professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trustin London. “As an oncologist who helps patients deal with this terrible disease, I hope that nivolumab will now be made available as widely as possible, offering this group of patients a new treatment option that can potentially improve their overall survival.”
The approval was based on results from CheckMate 141, a global phase III, open-label, randomized trial, first published by Ferris et al in The New England Journal of Medicinelast October, which evaluated nivolumab vs investigator’s choice of therapy in patients aged 18 years and above with recurrent or metastatic, platinum-refractory squamous cell carcinoma of the head and neck who had tumor progression during or within 6 months of receiving platinum-based therapy administered in the adjuvant, neoadjuvant, primary, or metastatic setting. Investigator’s choice of therapy included methotrexate, docetaxel, or cetuximab. The primary endpoint was overall survival. The trial’s secondary endpoints included progression-free survival and objective response rate.
In the interim analysis of the pivotal trial, nivolumab demonstrated statistically significant improvement in overall survival with a 30% reduction in the risk of death (hazard ratio [HR] = 0.70, 95% confidence interval [CI] = 0.53–0.92, P = .0101]), and a median overall survival of 7.5 months (95% CI = 5.5–9.1) for nivolumab compared with 5.1 months (95% CI = 4.0–6.0) for the investigator’s choice arm. There were no statistically significant differences between the two arms for progression-free survival (HR = 0.89, 95% CI = 0.70–1.13) or objective response rate (13.3% [95% CI = 9.3–18.3] vs 5.8% [95% CI = 2.4–11.6] for nivolumab and investigator’s choice, respectively). The European Comission approval was based on updated study results, which will be presented at the 53rd ASCO Annual Meeting.
Patient-reported outcomes were evaluated using the following European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment: EORTC QLQ-C30, EORTC QLQ-H&N35, and 3-level EQ-5D instruments. Patients treated with nivolumab exhibited stable patient-reported outcomes, whereas those assigned to investigator’s choice of therapy exhibited significant declines in functioning (eg, physical, role, social) and health status as well as increased symptomatology (eg, fatigue, dyspnea, appetite loss, pain, and sensory problems).
The safety profile of nivolumabin CheckMate 141 was consistent with prior studies in patients with melanoma and non–small cell lung cancer. Serious adverse reactions occurred in 49% of patients receiving nivolumab. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, aspiration pneumonia, respiratory failure, respiratory tract infection, and sepsis.